WO2007150075A3 - Compositions comprising nanoparticulate meloxicam and controlled release hydrocodone - Google Patents

Compositions comprising nanoparticulate meloxicam and controlled release hydrocodone Download PDF

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Publication number
WO2007150075A3
WO2007150075A3 PCT/US2007/072054 US2007072054W WO2007150075A3 WO 2007150075 A3 WO2007150075 A3 WO 2007150075A3 US 2007072054 W US2007072054 W US 2007072054W WO 2007150075 A3 WO2007150075 A3 WO 2007150075A3
Authority
WO
WIPO (PCT)
Prior art keywords
hydrocodone
compositions
composition
component
controlled release
Prior art date
Application number
PCT/US2007/072054
Other languages
French (fr)
Other versions
WO2007150075A2 (en
Inventor
Paul Stark
John Devane
Niall Fanning
Gary Liversidge
Scott Jenkins
Gurvinder Singh-Rekhi
Original Assignee
Elan Pharma Int Ltd
Paul Stark
John Devane
Niall Fanning
Gary Liversidge
Scott Jenkins
Gurvinder Singh-Rekhi
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Elan Pharma Int Ltd, Paul Stark, John Devane, Niall Fanning, Gary Liversidge, Scott Jenkins, Gurvinder Singh-Rekhi filed Critical Elan Pharma Int Ltd
Priority to MX2008016115A priority Critical patent/MX2008016115A/en
Priority to EP07784540A priority patent/EP2032139A4/en
Priority to AU2007260822A priority patent/AU2007260822B2/en
Priority to CA002660650A priority patent/CA2660650A1/en
Priority to JP2009516757A priority patent/JP2009541360A/en
Publication of WO2007150075A2 publication Critical patent/WO2007150075A2/en
Publication of WO2007150075A3 publication Critical patent/WO2007150075A3/en
Priority to IL196066A priority patent/IL196066A0/en
Priority to NO20090119A priority patent/NO20090119L/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5107—Excipients; Inactive ingredients
    • A61K9/513—Organic macromolecular compounds; Dendrimers
    • A61K9/5138—Organic macromolecular compounds; Dendrimers obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5107—Excipients; Inactive ingredients
    • A61K9/513—Organic macromolecular compounds; Dendrimers
    • A61K9/5161—Polysaccharides, e.g. alginate, chitosan, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B82—NANOTECHNOLOGY
    • B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery

Abstract

The invention relates to a compositions comprising a nanoparticulate meloxicam composition in combination with a multiparticulate modified release hydrocodone composition that, upon administration to a patient, delivers a hydrocodone in a bimodal or multimodal manner. The multiparticulate modified release composition comprises a first component and at least one subsequent component; the first component comprising a first population of hydrocodone - comprising particles and the at least one subsequent component comprising a second population of hydrocodone-comprising particles, wherein the combination of the components exhibit a bimodal or multimodal release profile. The invention also relates to a solid oral dosage form comprising such a combination composition.
PCT/US2007/072054 2006-06-23 2007-06-25 Compositions comprising nanoparticulate meloxicam and controlled release hydrocodone WO2007150075A2 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
MX2008016115A MX2008016115A (en) 2006-06-23 2007-06-25 Compositions comprising nanoparticulate meloxicam and controlled release hydrocodone.
EP07784540A EP2032139A4 (en) 2006-06-23 2007-06-25 Compositions comprising nanoparticulate meloxicam and controlled release hydrocodone
AU2007260822A AU2007260822B2 (en) 2006-06-23 2007-06-25 Compositions comprising nanoparticulate meloxicam and controlled release hydrocodone
CA002660650A CA2660650A1 (en) 2006-06-23 2007-06-25 Compositions comprising nanoparticulate meloxicam and controlled release hydrocodone
JP2009516757A JP2009541360A (en) 2006-06-23 2007-06-25 Composition comprising nanoparticulate meloxicam and controlled release hydrocodone
IL196066A IL196066A0 (en) 2006-06-23 2008-12-18 Compositions comprising nanoparticulate meloxicam and controlled release hydrocodone
NO20090119A NO20090119L (en) 2006-06-23 2009-01-09 Composition comprising controlled release nanoparticulated meloxicam and hydrocodone

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US81588406P 2006-06-23 2006-06-23
US60/815,884 2006-06-23

Publications (2)

Publication Number Publication Date
WO2007150075A2 WO2007150075A2 (en) 2007-12-27
WO2007150075A3 true WO2007150075A3 (en) 2008-04-24

Family

ID=38834447

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2007/072054 WO2007150075A2 (en) 2006-06-23 2007-06-25 Compositions comprising nanoparticulate meloxicam and controlled release hydrocodone

Country Status (11)

Country Link
EP (1) EP2032139A4 (en)
JP (1) JP2009541360A (en)
KR (1) KR20090023729A (en)
CN (1) CN101484169A (en)
AU (1) AU2007260822B2 (en)
CA (1) CA2660650A1 (en)
IL (1) IL196066A0 (en)
MX (1) MX2008016115A (en)
NO (1) NO20090119L (en)
WO (1) WO2007150075A2 (en)
ZA (1) ZA200810098B (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8808740B2 (en) 2010-12-22 2014-08-19 Purdue Pharma L.P. Encased tamper resistant controlled release dosage forms
US9149533B2 (en) 2013-02-05 2015-10-06 Purdue Pharma L.P. Tamper resistant pharmaceutical formulations
US9522135B2 (en) 2009-04-24 2016-12-20 Iceutica Pty Ltd. Formulation of indomethacin

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040234602A1 (en) 2001-09-21 2004-11-25 Gina Fischer Polymer release system
US20040253310A1 (en) 2001-09-21 2004-12-16 Gina Fischer Morphine polymer release system
ES2360102T3 (en) 2003-03-26 2011-05-31 Egalet A/S SYSTEM FOR CONTROLLED RELEASE OF MORPHINE.
AU2008258596B2 (en) 2007-06-04 2013-02-14 Egalet Ltd Controlled release pharmaceutical compositions for prolonged effect
US20090311335A1 (en) * 2008-06-12 2009-12-17 Scott Jenkins Combination of a triptan and an nsaid
NZ594207A (en) 2009-02-06 2013-03-28 Egalet Ltd Immediate release composition resistant to abuse by intake of alcohol
JP6072539B2 (en) 2009-05-27 2017-02-01 アルカーメス ファーマ アイルランド リミテッド Reduction of flaky aggregation in nanoparticulate active agent compositions
EP2445487A2 (en) 2009-06-24 2012-05-02 Egalet Ltd. Controlled release formulations
CA2822769C (en) 2010-12-23 2016-10-04 Purdue Pharma L.P. Tamper resistant solid oral dosage forms
EP2586429A1 (en) * 2011-10-26 2013-05-01 Freund Pharmatec Ltd. Multi-unit drug delivery device for pulsatile or sustained release
CN103070906A (en) * 2011-12-08 2013-05-01 赵联华 Quality control method of injection composition for treating orthopedic diseases
JP5902318B2 (en) * 2011-12-29 2016-04-13 ラボラトリオス アンドロマコ ソシエダッド アノニマ Vaginal ring containing meloxicam and an agent that regulates the release of active ingredient and can be used for continuous use contraception in women
EP2877161A1 (en) 2012-07-06 2015-06-03 Egalet Ltd. Abuse deterrent pharmaceutical compositions for controlled release
US10751287B2 (en) 2013-03-15 2020-08-25 Purdue Pharma L.P. Tamper resistant pharmaceutical formulations
US9526734B2 (en) 2014-06-09 2016-12-27 Iceutica Pty Ltd. Formulation of meloxicam
US9132096B1 (en) 2014-09-12 2015-09-15 Alkermes Pharma Ireland Limited Abuse resistant pharmaceutical compositions
WO2021257784A1 (en) * 2020-06-18 2021-12-23 Verté Therapeutics, Llc Injectable meloxicam formulations
CN115025066B (en) * 2021-05-25 2023-05-16 重庆市畜牧科学院 Preparation method of traditional Chinese medicine slow-release particles with stable quality and capable of resisting diarrhea of piglets

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040176402A1 (en) * 2000-02-08 2004-09-09 Benjamin Oshlack Controlled-release compositions containing opioid agonist and antagonist
US20040229038A1 (en) * 2003-03-03 2004-11-18 Elan Pharma International Ltd. Nanoparticulate meloxicam formulations
US20040266807A1 (en) * 1999-10-29 2004-12-30 Euro-Celtique, S.A. Controlled release hydrocodone formulations

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RS49982B (en) * 1997-09-17 2008-09-29 Euro-Celtique S.A., Synergistic analgesic combination of opioid analgesic and cyclooxygenase-2 inhibitor
JP4613275B2 (en) * 1998-11-02 2011-01-12 エラン ファーマ インターナショナル，リミティド Multiparticulate modified release composition
JP2005508939A (en) * 2001-10-12 2005-04-07 エラン ファーマ インターナショナル，リミティド Composition having combined immediate release and sustained release characteristics

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040266807A1 (en) * 1999-10-29 2004-12-30 Euro-Celtique, S.A. Controlled release hydrocodone formulations
US20040176402A1 (en) * 2000-02-08 2004-09-09 Benjamin Oshlack Controlled-release compositions containing opioid agonist and antagonist
US20040229038A1 (en) * 2003-03-03 2004-11-18 Elan Pharma International Ltd. Nanoparticulate meloxicam formulations

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9522135B2 (en) 2009-04-24 2016-12-20 Iceutica Pty Ltd. Formulation of indomethacin
US8808740B2 (en) 2010-12-22 2014-08-19 Purdue Pharma L.P. Encased tamper resistant controlled release dosage forms
US9393206B2 (en) 2010-12-22 2016-07-19 Purdue Pharma L.P. Encased tamper resistant controlled release dosage forms
US9572779B2 (en) 2010-12-22 2017-02-21 Purdue Pharma L.P. Encased tamper resistant controlled release dosage forms
US9149533B2 (en) 2013-02-05 2015-10-06 Purdue Pharma L.P. Tamper resistant pharmaceutical formulations
US9579389B2 (en) 2013-02-05 2017-02-28 Purdue Pharma L.P. Methods of preparing tamper resistant pharmaceutical formulations

Also Published As

Publication number Publication date
AU2007260822A1 (en) 2007-12-27
CN101484169A (en) 2009-07-15
MX2008016115A (en) 2009-01-20
EP2032139A2 (en) 2009-03-11
AU2007260822B2 (en) 2012-07-05
EP2032139A4 (en) 2012-08-22
NO20090119L (en) 2009-03-20
ZA200810098B (en) 2009-12-30
KR20090023729A (en) 2009-03-05
IL196066A0 (en) 2009-09-01
WO2007150075A2 (en) 2007-12-27
CA2660650A1 (en) 2007-12-27
JP2009541360A (en) 2009-11-26

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